For the Approval Process of GMOs: The Japanese Case

Transcription

1 For the Approval Process of GMOs: The Japanese Case AgBioForum, 16(2): AgBioForum. Ayako Ebata Georg-August-Universität Göttingen, Germany Maarten Punt and Justus Wesseler Technische Universität München, Freising, Germany This article reviews the approval process of genetically modified organisms (GMOs) in Japan. The purpose of this review is to explain the Japanese safety approval procedures for food, feed, and imported GMOs and place it in an international context through a comparison with the United States and the European Union (EU). While the regulatory regime in the United States and EU is often discussed, little is understood about the Japanese regulations. However, Japan plays an important role in terms of biotechnological development as well as international trade through agricultural and food imports. Therefore, this article tries to fill the gap in the existing literature. Within Japanese regulations, GMOs are first tested following the Cartagena Protocol on Biosafety. In a second and final step, compliance with the national laws as well as food and feed safety is assessed. We also summarize the processes used in identity preservation and labeling of approved GMOs. The last section of the article reveals the pragmatic nature of Japanese GMO regulations as compared to the EU and the United States. Key words: GMOs, policies, regulations, Japan. Introduction Today the world faces the challenge of increasing agricultural production to meet the growing demands for food and plant-based fuels in an environmentally sustainable manner. The world s population is currently increasing and is projected to grow even further in the future. Studies suggest that the increasing population will require current food production to double by 2050 (Food and Agricultural Organization of the United Nations [FAO], 2009). In addition, producing fuel from agricultural commodities is becoming more important, and there is an on-going debate of food versus fuel (Edgerton, 2009). Many fear that the production of agricultural commodities cannot keep up with the increasing demand from the food as well as the fuel sectors (Cassman & Liska, 2007). However, some studies suggest that it is possible to supply enough agricultural commodities to meet the needs for both food and fuel if a significant increase in yield is achieved (Slade, 2012). In the past, yield increases have been driven through increasing inputs such as land and fertilizer (Ruttan, 2002). However, most fertile land is already under cultivation (Ramankutty, Foley, & Olejniczak, 2002). Therefore, the possibility to achieve production increases from using more land for agricultural production is limited. Also, further increases in input use such as fertilizer and pesticides generate concerns over the environmental impacts (Cassman & Liska, 2007). Since the beginning of the 20 th Century, the improvement of agricultural production technology has been the major driving force for increases in productivity. Conventional breeding has increased production quantities by selecting varieties with higher yields and higher resistance towards pests and diseases (Khush, 1995; Rosegrant & Cline, 2003). Currently, the technology of genetic modification (GM) is thought to have a strong potential to achieve further increases in agricultural productivity without increasing negative environmental impacts. Many current GM varieties are tolerant towards agricultural chemicals that are generally used. As a result, producers are able to apply others that are more efficient and therefore reduce the overall production inputs as well as costs (Persley, 2000; Phipps & Park, 2002; Qaim & Zilberman, 2003; Wesseler, Scatasta, & Fall, 2011). However, despite its potential, the application of biotechnology has always been controversial (FAO, 2001). As a result, public aversion towards genetically modified organisms (GMOs) is reflected in GMOrelated policies throughout the world (Lynch & Vogel, 2001). This article summarizes the GMO approval process in Japan. Little is understood about the Japanese regulations related to GMOs compared to the European Union (EU) and the United States. However, Japan plays an important role in development of biotechnology (Organisation for Economic Co-operation and Development [OECD], 2013; Science Council of Japan, 2010). Moreover, imported agricultural goods have a large share in the domestic market (Ministry of Agriculture, Forestry, and Fisheries [MAFF], 2007a). There-

2 AgBioForum, 16(2), Food Animal feed Others The Cartagena Protocol Research and development through experimental trials in the laboratory/mext Assessment on environmental safety and impacts on biodiversity in isolated field trials/maff, MOE Experimental cultivation in isolated fields Assessment on environmental safety and impacts on biodiversity in cultivation outside isolated fields for commercial purposes/maff, MOE Safety assessment of GMOs as food products/mhlw FSA FSBA AFSA FSBA Safety assessment of GMOs as animal feeds/maff Commercialization Figure 1. Safety approval process regarding GMOs in Japan. Source: Council of Biotechnology Information Japan (n.d.), MAFF (2007b). fore, understanding the GMO regulations in Japan is important. This article begins by providing an overview of GMO approval for food, feed, and imports in Japan, as well as currently approved GMOs. Then, the identity preserved handling (IP handling) process and labeling of GMOs is explained. The article then lays out a comparison between the Japanese GMO approval process and the process in the EU and the United States, followed by a summary and conclusion. GMO Approval Process in Japan General Overview By 2013, Japan has approved eight GM food and feed crops for human consumption and animal feeding purposes (Council of Biotechnology Information Japan, 2013; MAFF, 2013; MHLW, 2013). These are soybeans, sugar beet, corn, canola, cotton, alfalfa, potatoes, and papaya. All GMOs have been tested through approval processes under three national laws and the implementation of an international treaty, namely the Food Safety Basic Act (FSBA); the Food Sanitation Act (FSA); the Animal Feed Sanitation Act (AFSA, officially known as the Act on Safety Assurance and Quality Improvement of Feeds); and the Cartagena Protocol on Biosafety (Council of Biotechnology Information Japan, 2013; MAFF, 2007b). As described in Figure 1, all organisms are first tested at controlled experimental fields in terms of their impacts on biodiversity, following the Cartagena Protocol, under the supervision of the Ministry of Education, Sports, Science, and Technology (MEXT), the MAFF, and the Ministry of the Environment (MOE). Then, products for human consumption are assessed according to the FSA and the FSBA, while animal feed crops are studied following the AFSA as well as the FSBA (Council of Biotechnology Information Japan, n.d.; MAFF, 2007b). Step 1: The Cartagena Protocol The goal of the Cartagena Protocol is to ensure safety in terms of biodiversity conservation and human health when transporting and utilizing living modified organisms (LMOs) across borders (Ministry of Foreign Affairs of Japan, 2012). Although the Cartagena Protocol refers to LMOs, we will use the term GMOs for consistency. Based on the Cartagena Protocol, first all GMOs have to be proven safe for the local environment. Under the Japanese approval process, all GM food, processing aids, and food additives are subject to a safety assessment. It generally takes about a year for all organisms to go through the entire approval process. The Ministry of Health, Labour, and Welfare (MHLW) is the main entity in charge of the GMO approval procedure for human consumption, while MAFF is responsible for impacts on the environment, approval of feed crops, and labeling of GMOs (Gruère, 2006).

3 AgBioForum, 16(2), Developers and importers of GMOs in question Submit Biological Diversity Risk Assessment Report Request of safety approval Approve or reject Ministries MAFF MOE 1. Consult scientists 2. Ask for public opinions from the citizens Approve the safety of local animal & plant species biodiversity, if necessary Define necessary information in safe-handling of GMOs Publicly announce approved handling procedure and provided information Figure 2. Approval process of GMOs (agricultural plants and tree species) for Type 1 usage under the Cartagena Protocol. Corresponding ministries: MAFF, MOE. Source: MAFF (n.d.c); University of Tokyo, School of Science (n.d.) Approved GMO in developers, importers Obtain information after the application of approved GMOs Provide necessary information in safe-handling of the GMOs (defined in Step 1) Report the results and observations from field usage of the GMOs GMO utilizers (field) Obtain information Report results from self-investigation Request information, update on policy changes, etc. MAFF MAFF staffs Plant Protection Station (PPS) Animal Quarantine Service (AQS) others MOE staffs Regional offices Following ministries request, MAFF and MOE staffs and IAI conduct inspections MAFF MAFF MOE Ministries Report results of inspection MAFF-related Independent Administrative Institutions (IAI) Food & Agricultural Materials Inspection Center (FAMIC) National Center for Seeds & Seedlings (NCSS) National Livestock Breeding Center (NLBC) Fisheries Research Agency (FRA) Figure 3. Proper handling of GMOs approved for Type 1 usage. Corresponding ministries: MAFF, MOE. Source: MAFF (n.d.c) Under the Cartagena Protocol, all GMOs subjected to an assessment are first categorized into two groups those for Type 1 use and those for Type 2 use (MAFF, n.d.a). Type 1 use is defined as an open usage of GMOs, i.e., under conditions that may influence the local environment. Type 2 use involves a closed environment where impacts of GMOs are contained. Such applications are relevant in the case of an experimental field or isolated greenhouse (MOE, n.d.). Type 1 Usage. In order to have GMOs approved by the Cartagena Protocol for Type 1 usage, applicants of GMOs have to submit a Biological Diversity Risk Assessment Report to corresponding ministries (MOE, n.d.). The report must be based on research conducted through literature review and laboratory experiments (MOE, n.d.). The ministries will request more information from the applicants if there are possible adverse effects or a lack of information on biological safety. If no adverse effect is observed, they will consult the public and the applications will be further assessed according to the FSA or AFSA, depending on their purposes. Ministries that receive applications include MAFF, MHLW, MOE, and MEXT. In the case of Type 1 usage, MOE is always involved, as the main concern of the assessment is the environmental impacts of the GMOs in question. Figure 2 illustrates the procedure of assessment of GMOs for Type 1 usage. After GMOs are approved for Type 1 usage, the Cartagena Protocol further requires appropriate monitoring and handling of the GMOs. As shown in Figure 3, importers or developers of approved GMOs are requested to continue obtaining information from field usage, which is to be submitted to the MAFF and the MOE. Independent administrative institutions (IAIs) conduct inspections following requests from both minis-

4 AgBioForum, 16(2), Table 1. Corresponding ministries in charge for Type 2 approval. Ministries in charge Type 2 uses by category Ministry of Agriculture, Forestry, & Fisheries Improvements to crops in equipment, development of live vaccines for animals Ministry of Health, Labour, & Welfare Viruses for gene therapy Ministry of Education, Culture, Sports, Science, & Technology Uses in the experiments of gene recombination in universities Use in research and development activities Ministry of Economy, Trade, & Industry Uses in the process of production of industrial enzymes National Tax Agency Yeast used in the production of alcoholic beverages Source: Ministry of the Environment (n.d.), Japan Biosafety Clearing House (2004) Case 1: Procedures to prevent diffusion of GMOs are already defined and advised by ministries Individuals or entities that intend to utilize the GMOs in question Comply with the defined procedures Gather reports, undertake inspection, order actions Report the situations in using the GMOs MAFF MOE Ministries Case 2: Such procedures are not defined or advised by ministries Individuals or entities that intend to utilize the GMOs in question Prepare the application to approve the GMOs Submit the application Confirm Undertake inspection, order actions MAFF Ministry MAFF MOE Ministries Figure 4. Approval process of GMOs (agricultural plants and tree species) for Type 2 usage under the Cartagena Protocol. Source: MAFF (n.d.c); University of Tokyo, School of Science (n.d.) tries. The purpose of such inspections is to ensure that the approved GMOs are produced and handled according to the regulations, to keep records through official documents, and to conduct scientific tests concerning the DNA structure. Different research units are in charge within the ministries depending on the purposes and types of usage of each GMO. Type 2 Usage. For Type 2 usage, applicants must comply with the procedure to avoid GMOs diffusion into the local environment. In some cases, corresponding ministries have already defined specific procedures to be undertaken. If this is the case, applicants can follow the already-existent procedures. If the standard has not been set, each application must be submitted to the appropriate ministries for approval. Such institutions include the MAFF, the MHLW, the MEXT, and the National Tax Agency (MAFF, 2007c; MOE, n.d.). Table 1 presents ministries in charge and Figure 4 graphically represents the approval process of GMOs for Type 2 usage. Summary on the Cartagena Protocol. In summary, the Cartagena Protocol requires assessment of each GMO whose environmental safety has not been tested yet. Individuals or institutions interested in utilizing specific GMOs in Japan must apply to the ministries concerned. They must file either a biological report to investigate the GMO s impact on the local environmental safety or a request to define safety instructions to be followed when handling such organisms. For Type 1 usage, after approving the environmental safety of GMOs, applicants and government entities will discuss the results of field experiments to ensure the safety obtained from actual observations. The GMOs will be assessed finally by the national laws only when proven to be safe in the local environment, complying with the Cartagena Protocol (MAFF, n.d.a). Generally speaking, applicants are developers of GM seeds and predominantly large international corporations. Such corporations include Monsanto Japan Co., DuPont, Bayer Crop Science, and Dow Chemical Japan Ltd. (MAFF, 2013).

5 AgBioForum, 16(2), MHLW Ministry Request evaluations Report the results Cabinet Office (CAO) Food Safety Commission (FSC) Submit application Report and announce Public Report the results Evaluate and discuss GMO applicant Exchange public opinions, information Investigation group for GM foods Figure 5. Approval of food item GMOs by the MHLW. Source: MHLW (2012) MAFF Ministry Inquiry Report Agricultural Material Council (feed safety assessment) Request evaluations Report the results Cabinet Office (CAO) Food Safety Commission (FSC) Investigation group for GM foods Submit application GMO applicant Report and announce Exchange public opinions, information Public Exchange public opinions, information Figure 6. Approval of GM feed items by the MAFF. Source: MAFF (n.d.c) Step 2: Food or Feed Safety Assessment After GMOs are proven to be safe under the Cartagena Protocol, they are further investigated, following the FSBA, the FSA, and the AFSA. Food items are assessed by the FSBA and the FSA, both of which are monitored by the MHLW; feed items are studied based on the FSBA of the MHLW as well as the AFSA of the MAFF. Food Safety Assessment. The MHLW requires each applicant to request food safety approval by genetic event. Then, the MHLW will submit the request to the Food Safety Commission of Japan (FSC) within the Cabinet Office (CAO) of Japan, which will consult a group of scientists for investigation. The general public will be informed about the newly-considered GMOs and can give feedback to the FSC. If the Minister of the MHLW approves the GMO s safety, it has completed the food-safety approval process. Finally, the public will be notified of the decision (MHLW, 2012). This approval process was made mandatory by the MHLW in 2001 (FSC, 2004). Figure 5 graphically illustrates the approval process of food GMOs by the MHLW. There are two laws that play a role in food-safety approval, i.e., the FSA and the FSBA. The FSBA emphasizes food safety for consumers (Ministry of Internal Affairs and Communications, 2011), whereas the FSA is concerned with preventing sanitation hazards caused from consuming food (Ministry of Internal Affairs and Communications, 2009). After the safety assessment is done within the CAO, the MHLW Minister will make the final decision, referring to the FSA as well as the FSBA (Honda, 2010). Feed Safety Assessment. Approval of feed GMOs is done by the MAFF. As described in Figure 6, the MAFF undertakes an assessment of feed safety within the ministry for each application. The assessment is carried out under the AFSA, which ensures feed safety and quality (Ministry of Internal Affairs and Communications, 2007). The act is concerned with feed produced domestically as well as imported. It also aims to promote

6 AgBioForum, 16(2), Importers with records of imports, importing cargos 1. Submit applications 2. Request order inspection, monitoring inspection Quarantine office Sampling Imported food quarantine inspection centers, registered inspection institutions If non-approved items are detected Rejection, recall, etc. If proven safe/non-approved items are not detected detected Imports permitted Figure 7. Procedure of quarantine on imported GM food items. Source: MHLW (2012), Kamada (2011) improvement of feed quality and to stabilize the supply of high-quality feed (Ministry of Internal Affairs and Communications, 2007). The MAFF also requires all GM feed items to go through the FSC within the CAO as in the case of food GMOs. The purpose is to investigate the impacts from GM feed on human health. Unlike in the case of food GMOs, this food-safety investigation addresses the safety of food products derived from animals fed with GMOs. This assessment is done following the FSBA (Honda, 2010). The public has the opportunity to express its opinions before feed GMOs are officially released (MAFF, n.d.c). Approval of GMOs for Imports Before importing GMOs, importers have to obtain approval for Type 1 usage in the Cartagena Protocol (Japan Biosafety Clearing House, n.d.). When importing GMOs, the MHLW conducts random inspections of GMOs at ports of entry. This has been in place since April 2001 to detect non-approved GMOs (MHLW, 2012). The MHLW has a 0% tolerance on GMOs that are not approved abroad. In other words, no import will be made unless exporting countries have certified their GM products safety through their own regulatory mechanisms (Gruère, 2006). The procedure of inspection is presented in Figure 7. Order inspection in the figure is what importers must comply with when they intend to import GM food items that may not satisfy the safety standards set by the Japanese regulations. In this case, the importers have to evaluate the organisms at registered inspection institutions at their own cost. Monitoring inspection occurs when the government proposes a guideline to conduct Table 2. Incurred costs by companies from discovery to authorization of a plant biotechnology trait. Costs ($ Category millions) Discovery Early discovery 17.6 Late discovery 13.4 Total cost 31.0 Construct optimization 28.3 Commercial event production & selection 13.6 Introgression breeding & wide-area testing 28.0 Regulatory science 17.9 Registration & regulatory affairs 17.2 Total Source: Phillips McDougall (2011) regular inspections in order to understand the current hygienic situation involving imported food items. As of March 2012 (MHLW, 2012), examples of GM items currently subject to inspections are rice (63Bt, NNBt, CpTI, LLRICE601), papaya (PRSV-YK), canola (RT73 B. rapa), and flaxseed (FP967). Since 2001, detected unapproved GMO items include 2 maize, 0 soybeans, 31 rice, 2 flaxseed, and 3 papaya events (MHLW, 2012). Time and Costs of GMO Approval A study done by CropLife International summarizes the results of a survey asking major biotechnology companies for the time duration and costs of plant biotechnology research and development (R&D) activities (Phillips McDougall, 2011). Questionnaires were sent to six major companies, namely BASF Corporation, Bayer

7 Table 3. Duration of each activity stage in the plant biotechnology trait R&D process (months). Event sold before 2002 Event introduced between AgBioForum, 16(2), Required to complete each stage in 2011 Category Duration % share Duration % share Duration % share Early discovery % % % Late discovery % % % Construct optimization % % % Commercial event production & selection % % % Introgression breeding & wide-area testing % % % Regulatory science % % % Registration & regulatory affairs % % % Total Source: Phillips McDougall (2011). CropScience, Dow AgroSciences, DuPont/Pioneer Hi- Bred, Monsanto, and Syngenta AG. Although there are no statistics available specifically for Japan, the aforementioned six corporations are the major players in approving GM traits in Japan. Therefore, the observations described in this section can be considered as an appropriate approximation for the situation in Japan. The key findings in the article suggest that the average dollar amount that surveyed companies spent on discovery, development, and approval of a new GM trait was a total of $136 million between 2008 and Out of the total costs, the R&D activities consisted of the highest share: 51% or $69.9 million, followed by approval process (26% or $35.1 million) and gene discovery (23% or $31.0 million). Table 2 summarizes incurred costs organized by categories of different activities. On average, the time duration for registration and regulatory affairs is 5.5 years as of 2011, while it was approximately 3.7 years prior to Table 3 shows the average duration of each activity undertaken by companies. The total time taken from discovery to commercialization has increased since When combining the regulatory science phase and the registration and regulatory affairs phase, the time involving regulatory processes is the longest phase that companies go through in all periods. The average time length of discovery projects is 13.1 years. It ranges from 11.7 years for canola to 16.3 years for soybeans, with corn (12.0 years) and cotton (12.7 years) in between. This excludes the duration of applying for regulatory approval. Currently Approved GMOs By April 2013, of the total of 166 approved events, 11 GM crops have been approved for Type 1 and Type 2 usage, following the Cartagena Protocol (MAFF, 2013). In order to identify the GMOs approved for Type 1 usage, this study uses the records published by both the MAFF and the MHLW. The list of all genetic events approved for food and/or feed can be found in the Appendix. It is organized based on commodities, which are potatoes, soybeans, canola, sugar beet, maize, cotton, alfalfa, and papaya. Besides these eight food and/or feed commodities, several flower species are also approved for Type 1 usage. In addition, rice and a number of other flowers have been approved for Type 2 usage (MAFF, 2013). Each commodity is further arranged according to the features of the GMOs. The table contains information on the applicants as well as the first date of approval. The date refers to the year that each trait was approved as a food and/or feed item. Identity Preservation Identity Preserved Handling Identity preserved (IP) handling of GMOs is enforced for imported GMOs (MAFF, n.d.b). In 2001, the Japan Food Industry Center (JAFIC) and the MAFF jointly published a logistics manual for IP handling of GM soybeans, maize, and potatoes. With the approval of GM papayas, the JAFIC published guidelines for IP handling of papayas in IP handling is necessary, as GM products need to be segregated and labeled properly by law. The regulations involving labeling will be revisited more thoroughly in the next section. IP handling is defined as the management method where any involved entities ensure careful handling to segregate GM and non-gm agricultural products through providing official statements at each stage involving production, transportation, and processing of

8 AgBioForum, 16(2), Cleaning of shipping equipment (tractors, cargos, ships) Cleaning of storing facilities Farm Farm Farm Collectors of raw material Processors (if processed) D Shipping companies D Exporters D Exporting country Segregation when seeding and harvesting Cleaning of shipping equipment and storage facilities Cleaning of storage facilities as well as loading equipment Avoiding mixing when loading Cleaning barge Cleaning of storage facilities at ports Segregation in transferring and separating Cleaning of processing machines Cleaning of storage facilities Importers D D Processors Wholesalers D D Food manufacturers In Japan Cleaning of storage facilities, transferring vehicles, etc. Segregation in transferring and separating Cleaning of processing machines Figure 8. IP handling in segregating GM soybeans, maize, potatoes, and papayas. D : official documents required Source: Japan Food Industry Center (2001, 2011), MAFF (n.d.b, 2002) GM and non-gm agricultural products (JAFIC, 2001, p. 5). For all four crops, the IP handling process starts from farms in an exporting country until the products reach the final manufacturing entities or consumers in Japan. Although there are slight differences across commodities, the IP handling procedures for all crops in question are rather alike. The standard procedure of IP handling is presented in Figure 8. Since the first exporter of GM soybeans, maize, potatoes, and papaya to Japan was North America, manuals were originally written specifically for imported GM and non-gm goods from the United States and Canada (MAFF, n.d.b). Now, the same IP handling procedure is imposed on other exporting nations if both GM and non-gm products are produced within the same country (JAFIC, 2001). For all GMOs, raw materials are first collected from individual farms by collectors and/or local processors. Then, products are transferred to exporters through shipping entities. When they reach Japan, importers distribute the products to processors or wholesalers. Finally, the products will be received by food manufacturers to reach consumers. At every step except for the first, it is required to ensure that the IP handling procedure is followed by providing official documents (JAFIC, 2001). In the figure, the D indicates the necessity to provide certifying documents. The documents should ensure safe and careful handling of GMOs, such as appropriate maintenance and cleaning of storing, as well as logistic facilities. Labeling GMOs in Japan All GM food products as well as their derivatives are subject to mandatory labeling under the Japanese regulations. Table 4 shows all product types subject to mandatory labeling. Labeling regulation has been in place since April 2001 under the Law on Standardization and Proper Labeling of Agricultural and Forestry Products introduced by the Japanese Agricultural Standards (JAS; Consumer Affairs Agency, Government of Japan, 2011). Under the Japanese labeling regulation, there are three

9 AgBioForum, 16(2), Table 4. Processed food items subject to mandatory labeling (as of August 2011). Raw materials: soybeans, maize, potato, canola, cotton, alfalfa, sugar beet, papaya; Processed food (33 food items) No. Ingredients Processed food 1 Soybean Tofu and fried tofu 2 Tofu-derived food items 3 Fermented soybeans 4 Soy milk 5 Miso paste 6 Boiled soybeans 7 Canned and bottled boiled soybeans 8 Soybean powder 9 Fried soybeans 10 Food items derived from Food items derived from soybeans 12 Food items derived from soybean powder 13 Food items derived from soybean protein 14 Edamame beans Food items derived from edamame beans 15 Soybean sprouts Food items derived from soybean sprouts 16 Maize Corn snacks 17 Corn starch 18 Pop corn 19 Frozen corn 20 Canned and bottled corn 21 Food items derived from corn flower 22 Food items derived from grinded corn (except for cornflakes) 23 Food items derived from corn 24 Food items derived from Potato Potato snacks 26 Dried potato 27 Frozen potato 28 Potato starch 29 Food items derived from Food items derived from potato 31 Alfalfa Food items derived from alfalfa 32 Sugar beet Food items derived from sugar beet 33 Papaya Food items derived from papaya Source: Consumer Affairs Agency, Government of Japan (2011). types of GMO labels. Products can be labeled as genetically modified, genetically modified organisms not segregated, or not genetically modified. The first two labeling options are mandatory if GMOs are included in the final products while the last option is voluntary. The labeling regulations in Japan focus on the final products. Unlike in the case of the EU, traceability is not enforced. Therefore, only when the final products contain the same DNA characteristics as the raw material, they need to be labeled as GM. In contrast, it is not necessary to label products if the end products do not preserve the DNA characteristics of the original crops. Vegetable oils and soy sauce are examples because their DNA characteristics are altered through processing. Furthermore, the regulations allow a 5% impurity with respect to the total weight of final products when GMOs are accidentally mixed in with non-gm products. Moreover, labeling is only necessary for the top three ingredients. In other words, the products can still be labeled as non-gm if the content of GMOs in the top three ingredients is less than 5% of the total weight. In the case of GM crops whose genetic and nutritional characteristics largely differ from their conventional counterparts, final products need to be labeled to identify how they differs from the conventional products (e.g., genetically modified to contain higher level of oleic acid in soybeans ; Consumer Affairs Agency, Government of Japan, 2011). Voluntary labeling of non-gm food items can be found on processed foods. If GMOs are segregated in the supply chain, products can be labeled as not genetically modified or sold without labels (Consumer Affairs Agency, Government of Japan, 2011). This applies to the food crops currently approved for human consumption (soybean, maize, potato, canola, cotton, alfalfa, sugar beet, and papaya). Food items for which GM counterparts do not exist cannot be labeled as non- GM. For instance, apples cannot be labeled as non-gm since there is no GM apple available in the market. When labeling as non-gm, producers need to clearly specify which ingredients the statement refers to (e.g., potatoes [not genetically modified] ). In general, the nature of GMO labeling regulations has driven GM products out of the market, failing to provide consumer choices (Gruère & Rao, 2007). Due to the fear of losing market share, companies tend to avoid producing GMO-derived products that require labelling. As a result, it is rare to find products at the retail level that are labelled GM. However, because traceability is not enforced and 5% impurity is allowed, consumers do get GMO-derived products without labels. Highly processed food items, such as soy oil and soy sauce, are examples of such products.

10 AgBioForum, 16(2), GMO-related regulations on labeling in Japan are looser than those in the EU but more stringent than those in the United States, Canada, and many other large exporters of GMOs. While the EU nations require traceability as well as labeling of derived and non-derived products, regulations in the United States, Canada, and Argentina only have voluntary labeling if the GM products do not demonstrate any difference in the final products, i.e., they are substantially equivalent (Gruère, 2006). As mentioned above, Japan imports large amounts of agricultural products from many of the leading producers of GM products. While it is certain that Japan imports GM crops, the final products are not labeled as such because the imported products are largely used for animal feeds as well as processed foods that do not preserve the DNA characteristics of the raw materials. Regional Comparison This section presents a regional comparison in the number of GMOs approved and the year of GMO approval between Japan, the EU, and the United States. As seen in the labeling regime, Japan s regulations for GMOs are often described as more stringent than in the United States but looser than in the EU. One way to observe this is to compare the years when the same GM events were approved in each region. Another is to look at the number of approved events over time. A comparison was made using the GMO Compass from MAFF (2013) for Japan; GMO Compass (2013) for the EU; and US Department of Agriculture, Animal and Plant Health Inspection Service (APHIS) for the United States (2013). In the case of Japan, the approval year is defined as the year the GMO was approved as safe following the food-safety assessment. The reason for this is that both food and feed GMOs have to pass the food-safety assessment to be officially released. Therefore, this date can be considered as the final assessment date of GMOs. For the EU, the date when the European Commission s decision was made is utilized, while the Federal Register (FR) ruling and determination date was used for the United States. Table 5 summarizes all GMOs accepted in each region. Blanks mean that the GMOs have not been accepted or approval has not been explicitly reported. Generally speaking, GMOs are approved first in the United States, followed by Japan and then the EU. For instance, the canola event T45 was approved in 1998 in the United States, 2001 in Japan, and finally 2009 in the EU. Similarly, the maize event NK603 was approved in Figure 9. Number of GMO approvals in Japan, the European Union, and the United States in the United States, 2001 in Japan, and 2005 in the EU. Assuming applications for approval have been submitted at the same point in time at least for the EU and Japan, this supports the expectation that the Japanese regulatory regime lies between the EU and the United States. Further analysis has to consider the submission date, which is difficult to obtain in the case of Japan. Figure 9 illustrates the evolution of the number of GMO events accepted in each region over time. Among the three regions under discussion, the United States is the first country that started approving GMOs. Japan followed with its first approval in 1999 and Europe s first approval after the quasi moratorium was in As of 2013, the United States, Japan, and the EU have approved a total of 106, 58, and 18 events, respectively. The United States has a relatively stable growth of GMO approvals, while Japan observed a significant increase between 1999 and Note that this comparison was made only on single events or non-stacked traits. This is because Japan and the EU present explicit approval in the sources utilized but the United States does not. Therefore, all the stacked events are excluded from the comparison for this study. Although explaining the causes of such regional difference in duration of GMO approval is beyond the scope of this study, Table 6 may provide some useful insights. It presents the dates when a GM event was submitted for approval and when it was accepted in each region. For Japan, we use the date when each event was authorized for protected field experiments as the date of application submission since the application date is not provided by the ministries. Generally speaking, Japan takes approximately 2 years between application sub-

11 Table 5. Comparison of GMO approval processes in Japan, the European Union, and the United States AgBioForum, 16(2), Crop Genetic event Japan EU US Crop Genetic event Japan EU US Maize Soybeans A *DAS A *DAS CV *MON810*NK *59122*MON810*NK603* 2012 DP MIR *MIR604*NK DP * *MON810*NK DP *MON810*MIR162*NK G94-1, G94-19, G *NK MON *Bt11*MIR604*GA MON87701*MON MON MON , 678, W62, W98, A , 1996 A , A Canola CDC Triffid 1999 B GT Bt GT Bt11*DAS *MIR604* 2011 MS *GA21 Bt11*GA MS1RF Bt11*MIR162*1507*GA MS1RF Bt11*MIR162*MIR604*GA MS Bt11*MIR MS8RF Bt11*MIR604*GA MS8*RF3*RT Bt11*MIR162*GA pcgn /86-18 & 23 CBH RF DAS RT DAS RT DAS *1507*NK T DAS *NK Topas19/ DBT WESTAR-Oxy DLL Sugar GTSB DP beet H DP T Event Cotton GA GA21*MON HCEM LY LY038*MON * MIR * MIR162*GA21 (sweet corn) MIR a 1996

12 AgBioForum, 16(2), Table 5. Comparison of GMO approval processes in Japan, the European Union, and the United States Crop Genetic event Japan EU US Crop Genetic event Japan EU US Maize MIR604*GA Cotton, 281* cont d MON cont d 281*3006* MON *3006*MON MON MON87460*MON89034* MON88017 MON87460*MON89034* 2011 BXN 1994 NK603 MON87460*NK COT MON COT67B MON Events & MON810*MON GHB MON GHB614*LLCotton MON863*MON810*NK LLCotton MON863*NK LLCotton25* MON MON MON MON88913 (Pima cotton) 2010 MON88017*MON MON88913* MON T304-40XGHB MON89034*1507* 2008 Alfalfa J DAS *MON88017 MON89034*1507*MON88017* 2013 J101*J DAS *DAS40278 MON89034*1507*NK J MON89034*1507*NK603* 2013 Papaya DAS40278 MON89034*MON MON89034*NK X MS Potatoes BT6, BT10, BT12, BT16, 1995 BT17, BT18, BT23 MS EH NK EH NK603*DAS RBMT15-101, SEMT15-02, 1999 SEMT15-15 NK603*MON RBMT & RBMT NK603*T RBMT T SBT02-5 & -7, ABBT04-6 & , -30, -31, -36 T Rice LLRICE06, LLRICE T25*MON LLRICE TC Source: MAFF (2013), GMO Compass (2013), USDA APHIS (2013) mission and approval, while the EU takes 2 to 4 years and the United States goes through the process relatively faster. Conclusions This article summarized the GMO approval process in Japan. It gave an overview of the assessment based on

13 Table 6. Comparison of time length between application approval and acceptance. Japan EU US AgBioForum, 16(2), Applied* Accepted Applied Accepted Applied Accepted MON89788 May 2, 2006 January 31, 2008 November 10, 2006 December 4, 2008 June 27, 2006 July 3, 2007 H7-1 May 25, 2005 April 24, 2007 November 26, 2004 October 24, 2007 July 29, 2010 July 20, 2012 MIR604 May 25, 2005 August 23, 2007 February 18, 2005 November 30, 2009 August 2, 2006 March 16, 2007 MON89034 May 2, 2006 January 31, 2008 January 2007 October 30, 2009 October 24, 2006 July 24, 2008 * approved for protected field experiments Source: MAFF (2013), GMO Compass (2013), USDA APHIS (2013) the Cartagena Protocol as well as national regulations that are in place to ensure safe utilization and commercialization of the GMOs. The labeling regime and the IP handling process were also discussed. Finally, an international comparison was made on different GMO approval processes in Japan, the EU, and the United States. Japan s regulatory regime is often described as less stringent than that in the EU, but is stricter than in North America. However, there was only limited information available about the Japanese regulatory framework to evaluate GMOs. This article contributes to the literature by providing a detailed description of the Japanese regulations as well as evidence for the claims about the strength of its regulation. Another contribution of this article is the international comparison of GMO approvals. This study revealed that Japan generally approves GMOs after the United States and before the EU. Also, the trend of the number of approved GMOs suggests that the United States and Japan have approved the same number of GMOs since 1994 while the EU approval has been less than half that amount. This study provided empirical observations that the Japanese GMO regulations are, in fact, stricter than in the United States but looser than in the EU. Japan has responded to the GM technology in a cautious manner and intended to provide both GM and non- GM options in its domestic market. However, this attempt has not been successful, as GMOs are generally used for highly-processed food or feed, thus avoiding the legal responsibility to label the products as GM. The approval process complies with international as well as national laws to ensure safety from utilization of GMOs through consumption, production, and logistics. As the portion of agricultural land devoted to production of GMOs increases throughout the world, Japan may face challenges in securing enough non-gm agricultural products to meet the demand. In summary, Japan s policies involving GMOs are likely to become more and more important in the future. References Consumer Affairs Agency, Government of Japan. (2011). 食品表示に関する共通 Q&A ( 第 3 集 : 遺伝子組換え食品に関する表示について ) [Frequently asked questions regarding food labelling: The case of genetically modified organisms]. Tokyo: Author. Cassman, K.G., & Liska, A.J. (2007). Food and fuel for all: realistic or foolish? Biofuels, Bioproducts and Biorefining, 1(1), Council of Biotechnology Information Japan. (n.d.). 安全性審査の流れ [GMO approval of safety in Japan]. Tokyo: Author. Available on the World Wide Web: japansystem/current_safety_review.html. Council of Biotechnology Information Japan. (2013). 日本における承認済み遺伝子組み換え作物一覧 [List of GMOs approved in Japan]. Tokyo: Author. Available on the World Wide Web: Edgerton, M.D. (2009). Increasing crop productivity to meet global needs for feed, food, and fuel. Plant Physiology, 149(1), Food and Agricultural Organization of the United Nations (FAO). (2001). Genetically modified organisms, consumers, food safety and the environment. Rome: Author. Available on the World Wide Web: x9602e00.htm. FAO. (2009, June 24). How to feed the world in Proceedings of the expert meeting on how to feed the world in Rome, Italy: Author. Food Safety Commission of Japan. (2004). 遺伝子組換え食品 ( 種子植物 ) の安全性評価基準 [The standards of safety evaluation for genetically modified food items]. Tokyo: Author. GMO Compass. (2013). GMO database: Genetically modified food and feed authorization in the EU [database]. Darmstadt, Germany: Author. Available on the World Wide Web: Gruère, G.P. (2006, February). An analysis of trade related international regulations of genetically modified food and their effects on developing countries (EPT Discussion Paper No. 147). Washington, DC: International Food Policy Research

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